Analyst (HPLC), Quality Control

United States·Tustinmid

OtherQuality Control

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Quick Summary

Key Responsibilities

Perform and review routine assays for HPLC and CE (Capillary Electrophoresis) with strict adherence to written analytical test procedures. Perform aseptic sampling, visual inspection,

Requirements Summary

BS in chemistry or biology or related field plus 2-4 years industry experience in a QC or analytical lab, or equivalent combination of education/experience.

Technical Tools

OtherQuality Control

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.

Your Role:
The Analyst (HPLC), Quality Control will perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment. This position requires a strong background in HPLC and supports/leads continuous improvement initiatives.

Key Responsibilities:

Perform and review routine assays for HPLC and CE (Capillary Electrophoresis) with strict adherence to written analytical test procedures.
Perform aseptic sampling, visual inspection, gowning and working in clean room areas, 5S methodology.
Review, revise and write test methods, standard operating procedures and perform trending analysis.
In addition to performing QC testing, the Analyst may be designated as study lead for validation projects, investigations and method development projects.
Other functions include, but are not limited to, writing study protocols and reports; training other analysts; working with other departments in developing, revising and implementing QC procedures and policies.
Knowledgeable of company cGMPs as well as industry regulations that apply to all job functions.
Participate in regulatory inspections to ensure laboratory is in compliance with current Good Manufacturing Practices.
Demonstrate and provide evidence to FDA officials that the laboratory operations conform to code of federal regulation.
Support continuous improvement initiatives by ensuring training relating to test methods, standard operating procedures, are up to date to comply with current good manufacturing practices.
Utilize Instruments software to perform calculations to minimize errors and eliminate time allocation for manual calculations.
Perform other duties as assigned.

Minimum Qualifications:

BS in chemistry or biology or related field plus 2-4 years industry experience in a QC or analytical lab, or equivalent combination of education/experience.
Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits are essential.
Must have strong HPLC, Analytical Biochemistry and Chemistry experience.
Must also have experience with most if not all of the following: protein characterization, electrophoresis, chromatography (normal phase, reverse phase, size exclusion, ion exchange, etc), aseptic techniques, assay and validation/qualification.

Position Type/Expected Hours of Work:

This role is a full-time onsite position. Days and hours of work are Monday through Friday, 8:00am to 5:00pm PST unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $25.76 to $32.21 hourly annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:
In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.